Zocor/Zocor HP

Simvastatin

Patients at high risk of CHD (w/ or w/o hyperlipidemia) including those w/ diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or w/ existing CHD to reduce the risk of CHD deaths, major vascular & coronary events, stroke, hospitalization for angina pectoris, & developing peripheral macrovascular complications in patients w/ diabetes; reduce the need for coronary revascularization procedures (including CABG & percutaneous transluminal coronary angioplasty), peripheral & other non-coronary revascularization procedures, & slows the progression of coronary atherosclerosis including reducing the development of new lesions & new total occlusions in hypercholesterolemic patients w/ CHD. Adjunct to diet to reduce elevated total-C, LDL-C, TG & Apo B, & to increase HDL-C in patients w/ primary hypercholesterolemia including heterozygous familial hypercholesterolemia (Fredrickson type IIa) or combined (mixed) hyperlipidemia (Fredrickson type IIb) when response to diet & other nonpharmacological measures is inadequate, therefore lowers LDL-C/HDL-C & total-C/HDL-C ratios. Patients w/ hypertriglyceridemia (Fredrickson type IV hyperlipidemia) or w/ primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia). Adjunct to diet & other non-dietary measures for the treatment of patients w/ HoFH to reduce elevated total-C, LDL-C & apo B. Adjunct to diet to reduce total-C, LDL-C, TG & apo B levels in adolescent boys & girls who are at least 1 yr post-menarche, 10-17 yr, w/ heterozygous familial hypercholesterolemia (HeFH).

Dose range: 5-80 mg/day as a single dose in the evening. If required, adjust dose at intervals of not <4 wk to a max of 80 mg/day as a single dose in the evening. 80 mg is recommended in patients at high risk of CV complications who have not achieved treatment goals on lower doses & when the benefits are expected to outweigh the potential risk. Patient at high risk of CHD or w/ existing CHD Initially 40 mg/day as a single dose in the evening. Hyperlipidemia Initially 20 mg/day as a single dose in the evening. Patient who requires a large reduction in LDL-C (>45%) Initially 40 mg/day as a single dose in the evening. Patient w/ mild to moderate hypercholesterolemia Initially 10 mg. HoFH 40 mg/day in the evening; 80 mg is only recommended when the benefits are expected to outweigh the potential risks. Concomitant therapy w/ lomitapide & amlodipine Max: 40 mg/day. Concomitant therapy w/ fibrates other than gemfibrozil or fenofibrate Max: 10 mg/day. Concomitant therapy w/ amiodarone, verapamil, diltiazem, or products containing elbasvir or grazoprevir Max: 20 mg/day. Severe renal insufficiency (CrCl <30 mL/min) >10 mg/day should be carefully considered. Ped patient 10-17 yr w/ heterozygous familial hypercholesterolemia Initially 10 mg once daily in the evening. Max: 40 mg/day.

May be taken with or without food.

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases. Concomitant administration of potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, HIV PIs, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, & drugs containing cobicistat); gemfibrozil, cyclosporine, or danazol. Pregnancy & lactation.

Risk of myopathy/rhabdomyolysis; predisposing factors for myopathy include advanced age (≥65 yr), female gender, uncontrolled hypothyroidism, & renal impairment; discontinue immediately if myopathy is diagnosed or suspected. Consider periodic CK determinations in patients starting therapy w/ simvastatin or whose dose is being increased. Temporarily stop therapy a few days prior to elective major surgery & when any major medical or surgical condition supervenes. Perform LFTs before treatment begins & thereafter when clinically indicated; patients titrated to 80 mg dose should receive an additional test prior to titration, 3 mth after titration to the 80 mg dose, & periodically thereafter (eg, semi-annually) for the 1st yr of treatment. Discontinue if transaminase levels persistently rise to 3 times the ULN. Patients who consume substantial quantities of alcohol &/or have a past history of liver disease. Not recommended w/ fusidic acid. Concomitant use w/ amiodarone, verapamil, diltiazem, amlodipine, lomitapide, moderate CYP3A4 inhibitor, breast cancer resistant protein (BCRP) inhibitor (eg, elbasvir & grazoprevir), niacin (≥1 g/day), daptomycin. Asian patients. Childn <10 yr or in pre-menarchal girls. Elderly ≥65 yr.

Abdominal pain, constipation & flatulence; asthenia & headache. Nausea, diarrhea, rash, lichen planus, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, insomnia, depression, vomiting, anemia, erectile dysfunction, & ILD.

Increased risk of myopathy/rhabdomyolysis w/ potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV PIs, boceprevir, telaprevir, nefazodone, drugs containing cobicistat), gemfibrozil, cyclosporine, danazol, other fibrates (except fenofibrate), fusidic acid, amiodarone, verapamil, diltiazem, amlodipine, lomitapide, moderate CYP3A4 inhibitors, niacin (≥1 g/day), colchicine, daptomycin. Increased plasma conc & risk of myopathy w/ transport protein OATP1B1 & BCRP inhibitors (eg, elbasvir & grazoprevir). Increased plasma levels of HMG-CoA reductase inhibitory activity w/ grapefruit juice. Potentiated effect of coumarin anticoagulants.

Dyslipidaemic Agents

C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

Rx